This Funding Opportunity Announcement (FOA) invites grant
applications for the Outstanding Investigator Award (R35) in any area of
cancer research.

The objective of the National Cancer Institute (NCI)
Outstanding Investigator Award (OIA) is to provide long-term support to
accomplished investigators with outstanding records of cancer research
productivity who propose to conduct exceptional research. The OIA is intended
to allow investigators the opportunity to take greater risks, be more
adventurous in their lines of inquiry, or take the time to develop new
techniques. The OIA would allow an Institution to submit applications
nominating established Program Directors/Principal Investigators (PDs/PIs)
for the NCI OIA.

It is expected that the OIA would provide extended funding
stability and encourage investigators to embark on projects of unusual
potential in cancer research. The research projects should break new ground
or extend previous discoveries toward new directions or applications that may
lead to a breakthrough that will advance biomedical, behavioral, or clinical
cancer research.

Key Dates

Posted Date

September 28, 2017

Open Date (Earliest Submission Date)

October 28, 2017

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

November 28, 2017, by 5:00 PM local time of applicant
organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

February/March 2018

Advisory Council Review

May 2018

Earliest Start Date

July 2018

Expiration Date

November 29, 2017

Due Dates for E.O. 12372

Not Applicable

Required
Application Instructions

It is critical that applicants follow the Research (R) Instructions
in the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all requirements (both
in the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are allowed.

Required
Registrations

Applicant
Organizations

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be completed
prior to the application being submitted. Registration can take 6 weeks or
more, so applicants should begin the registration process as soon as possible.
The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons requires
organizations to identify at least one Signing Official (SO) and at least one
Program Director/Principal Investigator (PD/PI) account in order to submit an
application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons. If the PD/PI is also the organizational Signing Official,
they must have two distinct eRA Commons accounts, one for each role. Obtaining
an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Only single PD/PI applications are allowed. Applications
with multiple PD(s)/PI(s) will not be accepted.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping
applications under review at the same time. This means that the NIH will
not accept:

A new (A0) application that is submitted before issuance of the
summary statement from the review of an overlapping new (A0) or resubmission
(A1) application.

A resubmission (A1) application that is submitted before issuance
of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application
pending appeal of initial peer review (see NOT-OD-11-101).

Additional Individual Eligibility
Requirements:

1) Applications must be submitted by Institutions who have
nominated a Program Director/Principal Investigator (PD/PI) with outstanding
cancer research productivity during the last 5 consecutive calendar years.

2)The Institution-nominated PD/PI must have been a PD/PI or
Project Leader of a research project, excluding cores, (of a NIH-defined
multi-project grant e.g., P01, P50, U54) on an eligible NCI research grant(s) continuously
since September 2012. Continuous funding is defined as receiving a Notice of
Award as PD/PI for an eligible NCI funded research grant in each Federal Fiscal
Year since FY 2012. Continuous funding does not include grants in a funded or
unfunded extension. Eligible NCI research grant mechanisms are defined as R01,
R15, R33, R35, R37, P01, P50, U01, U54, UM1, U19, U10, DP1, and DP2.

3) Due to the nature of this award, applicants are required
to devote at least 6 person months effort to the OIA. Applicants with
administrative responsibilities or other duties inconsistent with this time
commitment may apply but must reduce those other commitments to accept the
award.

4) PDs/PIs with effort on other grant support will be
expected to provide, as part of the Just-in-Time information, a detailed
explanation describing how effort on his/her other grants will be adjusted, if
necessary, to permit 6 person months on the OIA.

5) PD/PIs will need to renegotiate their time and effort on
other grant support, if necessary, in order to accommodate the OIA level of
effort.

In
addition, grantee Institutions are expected to:

1) provide clear and continuing substantial commitment to
the PD/PI, for example providing at least 20% salary support for the duration
of the award;

2) agree to relinquish the PD/PI's existing NCI funded
single PD/PI and single project research grants to allow them to be consolidated
into the OIA

Section IV. Application and Submission Information

1. Requesting an
Application Package

Buttons to access the online ASSIST system or to download
application forms are available in Part
1 of this FOA. See your administrative office for instructions if you plan
to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Research (R) Instructions
in the SF424
(R&R) Application Guide, including Supplemental
Grant Application Instructions except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in
the SF424 (R&R) Application Guide and should be used for preparing an
application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide
must be followed.

R&R Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Specific
Aims: Do not use. Specific Aims are not required.

Research
Strategy: Upload the Research Strategy as a single
attachment and organize the Research Strategy using the instructions provided
below. Start each section of the document with the appropriate section heading:

1) Evidence of PD/PI programmatic contributions: Explain how
you will leverage and translate the seminal past contributions of your cancer
research program (novel ideas; accomplishments; experience; sustained
productivity; etc.) into the new approaches proposed for your future research
program.
Discuss the reasons and the likelihood that your research program is likely to
continue to make novel and important contributions to cancer research.

2) Research Program description: What is the
broad scientific question or challenge in cancer research that will be
addressed and why is this important? Summarize the basis of the proposed
research program based on past accomplishments.

3) Overview of future research program: Describe in
broad terms the research vision, strategies and potential outcomes over the
next seven years. Describe how your goals build on your existing program and
past contributions or the current state-of-the-science. If the planned
research differs from your past or current work, explain how the new direction
relates to your current research activities and describe your ability to pursue
the new approaches and your rationale for the changes, such as the
development of new strategies and/or the posing of new hypotheses.

Limited preliminary data should be included only if they are
critical for assessing the feasibility of the new avenues of research.

The research strategy is expected to evolve over the next
seven years. Therefore, rather than a detailed experimental plan, a description
of the general approaches to be taken and the broad research questions to be
addressed should be provided.

Letters
of Support: Institutions must include a Letter of
Nomination for the applicant being proposed for the Outstanding Investigator
Award. The Letter of Nomination should be signed by the person at the
institution who has the authority to evaluate and endorse the outstanding
cancer research productivity of the nominee (e.g.: Dean, Center Director, etc.)
and commit the institution to all the requirements of the application and
award. Applications that are missing a Letter of Nomination will not be
reviewed.

In two
pages or less, the Letter of Nomination should describe:

1) The selection process used by the Institution to nominate
the PD/PI for the OIA;

2) A brief statement of the PD/PI's demonstrated outstanding
cancer research productivity for at least the past five years and the potential
for the PD/PI's cancer research productivity and influence to continue at the
same high caliber level;

3) The PD/PI's commitment of at least 6 person months effort
to the OIA. Applicants with administrative responsibilities or other duties
inconsistent with this time commitment may apply but must reduce those other
commitments to accept the award; and,

4) A clear and continuing substantial institutional
commitment to the PD/PI beyond the normal level extended by the Institution to
faculty, for example, providing 20% salary support for the duration of the
award.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
Application Guide.

Appendix:

Do not use the Appendix to circumvent page limits. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions
for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R)
Application Guide.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide
must be followed.

3. Unique Entity Identifier
and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the
requirement for obtaining a unique entity identifier and for completing and
maintaining active registrations in System for Award Management (SAM), NATO
Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and
Grants.gov

4. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to
submit applications before the due date to ensure they have time to make any
application corrections that might be necessary for successful submission. When
a submission date falls on a weekend or Federal
holiday, the application deadline is automatically extended to the next business
day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH's electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the application
due date and time. If a Changed/Corrected application is submitted after the
deadline, the application will be considered late. Applications that miss the
due date and time are subjected to the NIH Policy on Late Application
Submission.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

It is anticipated that the terms of
award will include, but not be limited to, the following:

1) Carryover of an unobligated balance from one budget
period to another budget period will require Grants Management Officer prior
approval.

2) Awards funded under this FOA will not be provided the
authority to extend the final budget period of the previously approved project
period one time for up to 12 months beyond the original expiration date shown
in the Notice of Award, as outlined in the NIH Standard Award Terms and
Conditions. All extensions, including the first extension, will require
NIH prior approval.

6) Change of grantee institution will be allowable, with NCI
prior approval, if the receiving institution agrees to all of the required OIA
terms.

7) It is expected that the OIA will replace all funded NCI
single project/single PD/PI grants that currently support up to 6 person months
of the PD/PIs effort. The level of effort on NCI single project/single
PD/PI grants will be based on the level of effort proposed in the competing
year of that affected grant. NCI funded multiple PD/PI and multiple
project grants as well as other NIH funding will be excluded; however, effort
on those grants will need to be accommodated outside the 6 calendar month
effort required on the OIA.

8) It is expected that the PD/PI will renegotiate effort on
other grant support, if necessary, to permit 6 person months effort to the
OIA. Applicants with administrative responsibilities or other duties
inconsistent with this time commitment must reduce those other commitments to
accommodate the OIA time and effort.

9) Evidence of a clear and substantial institutional
commitment to the PD/PI (e.g., 20% salary support for the duration of the
award).

10) Future applications submitted after the OIA is awarded
will not be folded into this award. However, the 6 person months level of
effort on the OIA must be maintained for the entire 7-year project period and
cannot be renegotiated

11) NCI will only consider funding two additional research
project grants to the Outstanding Investigator while the OIA is active.
This limit includes single PD/PI, multiple PD/PI and multi-project grants
where the OIA Investigator is the PD/PI.

12) Any grant that was relinquished at the time the OIA was
awarded should not be submitted for renewal and will not be considered for
funding by NCI.

7. Other Submission
Requirements and Information

Applications must be submitted electronically following the
instructions described in the SF424 (R&R) Application Guide. Paper
applications will not be accepted.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically. If you encounter a system issue beyond your control that threatens
your ability to complete the submission process on-time, you must follow the Guidelines
for Applicants Experiencing System Issues. For assistance with application
submission, contact the Application Submission Contacts in Section VII.

Important
reminders:

All PD(s)/PI(s) must include their eRA Commons ID in
the Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package. Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH. See Section III of this FOA for information on
registration requirements.

The applicant organization must ensure that the DUNS
number it provides on the application is the same number used in the
organization's profile in the eRA Commons and for the System for Award Management.
Additional information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness and compliance with application instructions by the Center for
Scientific Review, NIH. Applications that are incomplete or non-compliant will
not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in the policy.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

For
this particular announcement, note the following:

The Outstanding Investigator Award (R35) is meant to support
the cancer research program of individual scientists of exceptional creativity,
demonstrated outstanding research productivity, and seminal past contributions
in cancer research.

For this FOA, the research strategy is expected to evolve
over the seven-year award period. Applicants should describe a general
research strategy, providing an overview of the broad research questions/scientific
questions they plan to address, a general description of possible strategies
and a description of how their past scientific accomplishments will inform this
research. Experimental details, extensive preliminary data and specific aims
should not be included unless critical to assessing the feasibility of the new
avenues of research.

Accordingly,
reviewers will consider the following:

1) Evidence of important previous contributions made
by the PD/PI to their field (outstanding research quality; continuous record of
publications in peer-reviewed journals; landmark publications, honors and
awards received; etc.)

2) PD/PI's demonstrated outstanding cancer research
productivity of the highest quality for at least the past five years (since
September 2012)

3) Potential for the PD/PI's impact on cancer
research and influence to continue at the same high caliber level

4) Evidence of the appropriate level of effort to
accomplish the proposed program.

5) Substantial institutional commitment to the PD/PI
(e.g., 20% salary support for the duration of the award)

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Do the proposed research goals
address an important problem or a critical barrier to progress in the field?
Is there a strong scientific premise for the project? If the goals of the
research are achieved, how will scientific knowledge, technical capability,
and/or clinical practice be improved? How will successful completion of the
goals change the concepts, methods, technologies, treatments, services, or
preventative interventions that drive this field?

Specific to this FOA: Evaluate the
broad scientific challenge in cancer research that will be addressed, and why
this is important. Evaluate the pioneering approaches that, if successful,
might lead to groundbreaking or paradigm-shifting results to cancer research.
Evaluate the proposed goals for providing impetus for others working in related
areas.

Investigator(s)

Is the PD/PI well suited to the
proposed research goals in terms of important contributions to his/her field
(outstanding research quality; continuous record of publications in
peer-reviewed journals; landmark publications, honors and awards received;
etc.)? During at least the past five years, has the PD/PI demonstrated
outstanding productivity of the highest quality, innovation and influence in
cancer research? How has the PD/PI contributed to important and reliable data
to cancer research? If applicable, how has the PD/PI demonstrated
imagination, energy, and sensitivity to serendipitous findings in the past? Is
his/her influence likely to continue at the same high caliber level in the
future? Does the application indicate appropriate commitment of time and effort
for the proposed work? Evaluate how the PD/PI's research has influenced that of
others.

Innovation

Does the application challenge and
seek to shift current research or clinical practice paradigms by utilizing
novel theoretical concepts, approaches or methodologies, instrumentation, or
interventions? Are the concepts, approaches or methodologies, instrumentation,
or interventions novel to one field of research or novel in a broad sense? Is a
refinement, improvement, or new application of theoretical concepts, approaches
or methodologies, instrumentation, or interventions proposed?

Specific to this FOA: Has the
PD/PI provided evidence of the proposed research program's novelty in cancer
research? What PD/PI's insights have driven cancer research in new directions?
Do the stated goals reflect a fundamental new insight into the potential
solution of a problem, which may derive from the development of exceptionally
novel approaches and/or from the posing of radically unconventional
hypotheses?

Approach

Are the overall strategy and
approach well-reasoned and appropriate to accomplish the general aims of the
project? Have the investigators presented strategies to ensure a robust and
unbiased approach, as appropriate for the work proposed? Are potential
problems, alternative strategies, and benchmarks for success presented? If the
project is in the early stages of development, will the strategy establish
feasibility and will particularly risky aspects be managed? Have the
investigators presented adequate plans to address relevant biological
variables, such as sex, for studies in vertebrate animals or human subjects?

Specific to this FOA: In what way is
the PD/PI's work seminal in nature? Evaluate the PD/PI's broad plans for
research over the years of the award. How do the proposed goals facilitate
future planned research? Evaluate the likelihood that the PD/PI will continue
at the frontiers of research.

If the project involves human
subjects and/or NIH-defined clinical research, are the plans to address 1) the
protection of human subjects from research risks, and 2) inclusion (or
exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as
well as the inclusion or exclusion of children, justified in terms of the
scientific goals and research strategy proposed?

Environment

Will the scientific environment in
which the work will be done contribute to the probability of success? Are the
institutional support, equipment and other physical resources available to the
investigators adequate for the project proposed? Will the project benefit from
unique features of the scientific environment, subject populations, or
collaborative arrangements?

Specific to this FOA: Evaluate the
adequacy of the substantial institutional commitment to the PD/PI. Does the
application indicate a level of institutional commitment of support for the
PD/PI beyond the normal level extended by the Institution to faculty?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give separate
scores for these items.

Protections for Human Subjects

For research that involves human
subjects but does not involve one of the six categories of research that are
exempt under 45 CFR Part 46, the committee will evaluate the justification for
involvement of human subjects and the proposed protections from research risk
relating to their participation according to the following five review
criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3)
potential benefits to the subjects and others, 4) importance of the knowledge
to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human
subjects and meets the criteria for one or more of the six categories of
research that are exempt under 45 CFR Part 46, the committee will evaluate: 1)
the justification for the exemption, 2) human subjects involvement and
characteristics, and 3) sources of materials. For additional information on
review of the Human Subjects section, please refer to the Guidelines for the Review of Human
Subjects.

Inclusion of Women, Minorities,
and Children

When the proposed project involves
human subjects and/or NIH-defined clinical research, the committee will
evaluate the proposed plans for the inclusion (or exclusion) of individuals on
the basis of sex/gender, race, and ethnicity, as well as the inclusion (or
exclusion) of children to determine if it is justified in terms of the
scientific goals and research strategy proposed. For additional information on
review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion
in Clinical Research.

Vertebrate Animals

The committee will evaluate the
involvement of live vertebrate animals as part of the scientific assessment
according to the following criteria: (1) description of proposed procedures
involving animals, including species, strains, ages, sex, and total number to
be used; (2) justifications for the use of animals versus alternative models
and for the appropriateness of the species proposed; (3) interventions to
minimize discomfort, distress, pain and injury; and (4) justification for
euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia
of Animals. Reviewers will assess the use of chimpanzees as they would any
other application proposing the use of vertebrate animals. For additional
information on review of the Vertebrate Animals section, please refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether
materials or procedures proposed are potentially hazardous to research
personnel and/or the environment, and if needed, determine whether adequate
protection is proposed.

Resubmissions

For Resubmissions, the committee
will evaluate the application as now presented, taking into consideration the responses
to comments from the previous scientific review group and changes made to the
project.

Renewals

Not applicable

Revisions

Not applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Not applicable

Select Agent Research

Reviewers will assess the
information provided in this section of the application, including 1) the
Select Agent(s) to be used in the proposed research, 2) the registration status
of all entities where Select Agent(s) will be used, 3) the procedures that will
be used to monitor possession use and transfer of Select Agent(s), and 4) plans
for appropriate biosafety, biocontainment, and security of the Select Agent(s).

For projects involving key biological and/or chemical resources,
reviewers will comment on the brief plans proposed for identifying and ensuring
the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the
budget and the requested period of support are fully justified and reasonable
in relation to the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by NCI, in
accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications. Following
initial peer review, recommended applications will receive a second level of
review by the National Cancer Advisory Board. The following will be considered
in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons. Refer to Part 1 for dates for peer review, advisory council
review, and earliest start date.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications. The
NoA signed by the grants management officer is the authorizing document and
will be sent via email to the grantee's business official.

Awardees must comply with any funding restrictions described
in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be
subject to terms and conditions found on the Award
Conditions and Information for NIH Grants website. This includes any
recent legislation and policy applicable to awards that is highlighted on this
website.

Recipients of federal financial
assistance (FFA) from HHS must administer their programs in compliance with
federal civil rights law. This means that recipients of HHS funds must ensure
equal access to their programs without regard to a person's race, color,
national origin, disability, age and, in some circumstances, sex and religion.
This includes ensuring your programs are accessible to persons with limited
English proficiency. HHS recognizes that research projects are often limited
in scope for many reasons that are nondiscriminatory, such as the principal
investigator's scientific interest, funding limitations, recruitment
requirements, and other considerations. Thus, criteria in research protocols
that target or exclude certain populations are warranted where nondiscriminatory
justifications establish that such criteria are appropriate with respect to the
health or safety of the subjects, the scientific study design, or the purpose
of the research.

For additional guidance regarding how the provisions apply
to NIH grant programs, please contact the Scientific/Research Contact that is
identified in Section VII under Agency Contacts of this FOA. HHS provides
general guidance to recipients of FFA on meeting their legal obligation to take
reasonable steps to provide meaningful access to their programs by persons with
limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html.
The HHS Office for Civil Rights also provides guidance on complying with civil
rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html;
and http://www.hhs.gov/ocr/civilrights/understanding/index.html.
Recipients of FFA also have specific legal obligations for serving qualified
individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
Please contact the HHS Office for Civil Rights for more information about
obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS
Departmental goal to ensure access to quality, culturally competent care,
including long-term services and supports, for vulnerable populations. For
further guidance on providing culturally and linguistically appropriate
services, recipients should review the National Standards for Culturally and
Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in
Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal
Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal
Awardee Performance and Integrity Information System (FAPIIS) requirements.
FAPIIS requires Federal award making officials to review and consider
information about an applicant in the designated integrity and performance
system (currently FAPIIS) prior to making an award. An applicant, at its
option, may review information in the designated integrity and performance
systems accessible through FAPIIS and comment on any information about itself
that a Federal agency previously entered and is currently in FAPIIS. The
Federal awarding agency will consider any comments by the applicant, in
addition to other information in FAPIIS, in making a judgement about the
applicant's integrity, business ethics, and record of performance under Federal
awards when completing the review of risk posed by applicants as described in
45 CFR Part 75.205 "Federal awarding agency review of risk posed by
applicants." This provision will apply to all NIH grants and cooperative
agreements except fellowships.

A final RPPR, invention statement,
and the expenditure data portion of the Federal Financial Report are required for
closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

In accordance with the regulatory requirements provided at
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have
currently active Federal grants, cooperative agreements, and procurement
contracts from all Federal awarding agencies with a cumulative total value
greater than $10,000,000 for any period of time during the period of
performance of a Federal award, must report and maintain the currency of
information reported in the System for Award Management (SAM) about civil,
criminal, and administrative proceedings in connection with the award or
performance of a Federal award that reached final disposition within the most
recent five-year period. The recipient must also make semiannual
disclosures regarding such proceedings. Proceedings information will be
made publicly available in the designated integrity and performance system
(currently FAPIIS). This is a statutory requirement under section 872 of
Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010
of Public Law 111-212, all information posted in the designated integrity and
performance system on or after April 15, 2011, except past performance reviews
required for Federal procurement contracts, will be publicly available. Full
reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75
– Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.